FDA.reportPublic FDA data

Application 125545

Type
BLA
Sponsor
HOSPIRA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RETACRITEPOETIN ALFA-EPBXINJECTABLE;INJECTION2,000UNITS/MLNoNo
002RETACRITEPOETIN ALFA-EPBXINJECTABLE;INJECTION3,000UNITS/MLNoNo
003RETACRITEPOETIN ALFA-EPBXINJECTABLE;INJECTION4,000UNITS/MLNoNo
004RETACRITEPOETIN ALFA-EPBXINJECTABLE;INJECTION10,000UNITS/MLNoNo
005RETACRITEPOETIN ALFA-EPBXINJECTABLE;INJECTION40,000UNITS/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0069-1305RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1305RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1305RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1305RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1305RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1305RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1305RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1305RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1305RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1306RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1306RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1306RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1306RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1306RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1306RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1306RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1306RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1306RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1307RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1307RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1307RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1307RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1307RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1307RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1307RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1307RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1307RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1308RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1308RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1308RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1308RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1308RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1308RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1308RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1308RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1308RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1309RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1309RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1309RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1309RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1309RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1309RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1309RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1309RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1309RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1311RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1311RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1311RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1318RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1318RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
0069-1318RETACRITepoetin alfa-epbxPfizer Laboratories Div Pfizer IncBLACurrent
59353-002RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-002RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-002RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-002RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-002RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-002RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-002RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-002RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-002RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-003RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-003RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-003RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-003RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-003RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-003RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-003RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-003RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-003RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-004RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-004RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-004RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-004RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-004RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-004RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-004RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-004RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-004RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-010RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent
59353-010RETACRITepoetin alfa-epbxVifor (International) Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78649SUPPL 2024-06-05
78648SUPPL 2024-06-05
78635SUPPL 2024-06-05
74025SUPPL 2023-04-20
74024SUPPL 2023-04-19
63771SUPPL2020-07-01
63765SUPPL2020-07-01
63764SUPPL2020-07-01
57298SUPPL2019-01-22
57288SUPPL2019-01-22
57287SUPPL2019-01-22
56726ORIG2018-12-13
54190ORIG2018-05-15
54187ORIG2018-05-15
54186ORIG2018-05-15